Cardinal Health 200, LLC recalls Kendall SCD Comfort Sleeves Knee Length Small

Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller

On May 13, 2025, the firm began to notify customers via Urgent Medical Device Product Correction letters. Customers were informed of the issue, which exclusively impacts use of the Comfort Small Knee Sleeve. Other sleeve sizes are unaffected and operate as intended with the SmartFlow Controller. The product remains operational if the Comfort Small Knee Sleeve and SmartFlow Controller configuration is not utilized during therapy. A software update on the SmartFlow Controller is necessary before using the SmartFlow controller with the Comfort Small Knee sleeve configuration. Customers should discontinue use of the Comfort Small Knee Sleeve with the SmartFlow Controller and utilize a suitable alternative such as SM thigh or foot cuff. Customer service representatives will coordinate with customers to facilitate a software update which will allow the controllers to be utilized with the small knee sleeves without causing the error.

• FDA enforcement recordOfficial FDA database entry for Z-1918-2025
• FDA 510(k) clearance · K230028The device's official FDA premarket clearance record
• FDA device classification · JOWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.5800The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Cardinal Health 200, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.